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Roger, Please reread the draft guidance and the document where NICe give responses to individual questions. If it stays the same, which is highly likely, they aim to test a group of about 35,000 to begin with primarily using lab tests, with capacity being scaled up to eventually get to the 100,000 mark. They say GDR's point of care is best alternative. But what does that mean in sales terms being the second best option. It could mean 0 or it could mean £100,000 per anum over a couple of years at best while they scale up capacity. (Ollie Watkins was a good substitute for England, but he didn't get to play very much did he)

Boot, I think the trusts will want to avoid having to train people to use GDR's stroke test, when the primary method NICE recommended in draft guidance is to use lab tests for this.

You better hope no one actually reads those NICE guidance documents.

"The committee acknowledged that implementing testing

for everyone who has a stroke or transient ischaemic

attack (TIA) could be done in a stepwise process. This

would involve a gradual increase in numbers tested while

capacity was established. The committee suggested that

the NHS may need to identify subgroups of the overall

population to start offering testing to initially. If a group

was to be prioritised for earlier roll out of testing, there

would need to be capacity to test everyone in this group.

The committee recalled that, compared to no testing,

CYP2C19 testing after a non-minor stroke generated

more net monetary benefit (NMB) than testing after a

minor stroke or TIA. Estimates provided by the NICE

resource impact team indicate that the non-minor stroke

population equates to around 35,900 people per year

(rather than about 110,000 people who have any stroke

or a TIA). The committee concluded that to facilitate

implementation, testing could potentially be started in the

smaller non-minor stroke population before being

expanded to the minor stroke and TIA population.

The committee also agreed that point-of-care testing

should be considered as an alternative if laboratory based testing is not feasible at this scale, or for use while

capacity for laboratory-based testing is increased. These

considerations are in section 3.19 of the updated

guidance. An information box has also been added

below the recommendations to highlight these

implementation considerations (see ‘What this means in

practice’).

Roger, Read this sentence from NICE response. They only say "if":

"The committee also agreed that point-of-care testing should be considered as an alternative if laboratory based testing is not feasible at this scale, or for use while capacity for laboratory-based testing is increased."

Maj, If you read NICE comments, it sounds like they may not even use POC at all. We'll see, but I think this could become another GDR legacy product very quickly.

That's great then:

"The committee concluded that laboratory based tested was its preferred method to implement

testing."

BillyBob,

Go on NICE website and read actual NICE documents. This one is especially enlightening. Read down column on right: "NICE response":

https://www.nice.org.uk/guidance/gid-dg10054/documents/consultation-comments-and-responses-2

I wouldn't be surprised if you don't hear from GDR until results in November. I guess there's a chance they'll do an RNS after the NICE update, though wouldn't even bank on that.

Sorry, meant to say it'll hit 150p soon....lol

Sorrento/Amalfi coast absolutely amazing, though I bet it's even more expensive than the last time I was there years ago. I remember having a 600 euro bill just for the mini bar in the hotel room?! But I think you're more likely to hit 1.5p again before you hit 15p.

Here's another key paragraph from page 5:

The long-term health benefits of laboratory-based and point-of-care CYP2C19

genotype testing are very similar. But, some less-common loss-of-function CYP2C19

alleles occur at a higher rate in certain ethnic groups. This means that tests that only

identify the most common alleles may disproportionately fail to identify people with

loss-of-function alleles in these groups. Laboratory-based testing could identify a

wider range of alleles than point-of-care tests. It can also be changed more easily to

test for other pharmacogenomic markers if needed. Centralised laboratory testing

would also provide more consistency across the NHS. So, laboratory tests should be

used if possible.

From the NICE comments, they are kind of drawing a line of best fit. Basically they consider, cost, practicality and the outcomes all in one. And they said the best fit is lab testing. They said start with one drug if you have to wait for results, and then switch to another drug if that's what the test results advise when they come in.

Roger,

If you read NICE analysis of costing for CYP2C19 it clear that lab testing (in batches) is far, far cheaper than point of care.

I agree with you though that US could be good opportunity for AIHL. I think it shame GDR didn't go there sooner. However, would point out that to actually sell in the US significantly, they'll also need to get the product accepted by insurers and for the Medicaid and Medicare programs, so that would take a bit longer as well.

You're waiting for an update from NICE that will confirm they will use lab testing as their primary solution for clopidogrel (which of course GDR doesn't offer) Brilliant!

AIHL is definitely their best bet in my view. It's just taken rather a long time to get anywhere. Can you believe the NHS first started trying it out in Manchester in 2018! 6 years ago now....

There was no announcement. it's utter rubbish

Padrock,

I think this explains NICe thinking on your point (it does to me anyway).

NICE response:

Starting antiplatelet treatment should not be delayed while waiting for test results. The EAG’s model

included starting initial clopidogrel treatment and

changing to an alternative antiplatelet treatment later if

genotype testing indicated a loss-of-function allele was

present. The committee agreed that this was

appropriate, and that starting antiplatelet treatment

should not be delayed while waiting for test results.

These considerations are in section 3.20 of the updated

guidance.

https://www.nice.org.uk/guidance/gid-dg10054/documents/consultation-comments-and-responses-2

Has anyone seen an estimation of the TOTAL cost of the GDR stroke test? I think just the basic test itself without the device cost was £85 per test. Lab testing in batches (including the device cost) is only £44 per test. I seen estimation of the total cost for the cube point of care cost at £197!! My guess is total cost of GDR test would be at least three times more than lab test once device cost factored in. When you look at costs, lab testing wins by a very significant margin....

Only significant hope for the stroke product lies outside the UK in my view. Though medical bodies in different countries do tend to decide the same kind of thing to NICE in the end anyway, which means more genomic testing through labs. AIHL seems to be resilient to lab competition. Though it been a long road to get any where with it, and they still not very far along the road at all in terms of sales....